West Windsor firm working on medication to help those exposed to high levels of radiation

Christopher J. Schaber, PhD, president and CEO of Soligenix, a company working to develop vaccines against biological attacks, speaks with a reporter.Michael Mancuso/The Times

WEST WINDSOR — A company with a background in developing medications for use in extreme biohazard situations said it may one day have something humans can use in the event of a nuclear attack or reactor meltdown.

Soligenix, which for a while has been at work on an anthrax vaccine, is working on a medication to help the body rebound from heavy exposure to radiation.

The drug, OrbeShield, works on the gastrointestinal system, the health of which has been shown to be pivotal in the body’s ability to recover from radiation poisoning. In trials of the drug on dogs, the health of the digestive organs was somewhat improved, which in turn raised survival rates for the animals, the company reported late last year.

The company announced last week it has obtained FDA approval to fast-track the human testing process because of the potential value of the medication.

“We believe that OrbeShield has the potential to be a significant advancement in the preparation necessary for this nation to manage a public health emergency like a nuclear attack,” said CEO Christopher J. Schaber.

Soligenix is already developing vaccines for ricin toxin and anthrax, which are much feared as terrorist biological weapons. Soligenix’s RiVax and VeloThrax have drawn $9.4 million in federal funding.

OrbeShield, meanwhile, could prove useful in the event of a nuclear plant meltdown like the one in Japan at the Fukushima Daiichi plant in 2011.

Company officials said the active ingredient in OrbeShield, a corticosteroid called oral BDP, can help mitigate gastrointestinal acute radiation syndrome, which can kill within five days.

To date, “there is no established treatment or preventive measure for the GI damage that occurs after high-dose radiation,” the company said in a release.

OrbeShield has yet to be tested on humans but has shown statistically significant survival results for the treatment of gastrointestinal radiation in dogs, the company said.

The FDA has granted the drug “orphan” status, which means Soligenix doesn’t have to test the medication on large populations of test subjects. People with acute radiation sickness would be difficult to find for the testing, so smaller trials than usual will be allowed, officials said.

Orphan designation is the function of the 1983 Orphan Drug Act, which was crafted to encourage biopharmaceutical firms to develop drugs that fight rare diseases.

The status also guarantees the company exclusive marketing rights for seven years, assuming the drug is approved for use by humans, and allows Soligenix to apply for government grants for conducting clinical trials and tax credits.

According to CFO Joseph Warusz, the current patient population that could benefit from OrbeShield — and be drawn from to test it — is fewer than 200,000 Americans.
“Without getting the orphan designation, it would entail a much more expansive clinical trial,” Warusz said.

Funding opportunities now available to Soligenix are much more attractive than traditional financing strategies that require selling shares in the company to investors, he said.

“Now, we may be potentially able to attract government funding in the way of contracts or grants that do not require us to go out and raise capital through the public markets,“ he said.

OrbeShield’s active ingredient, BDP, has been marketed internationally as an inhalant since the early 1970s for treatment of allergic rhinitis and asthma.